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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ureteroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFGB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
AURIS HEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION -
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
DYNE MEDICAL GROUP INC.
  SUBSTANTIALLY EQUIVALENT 1
ELMED ELEKTRONIK VE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC
  SUBSTANTIALLY EQUIVALENT 1
HUGER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD,
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOVISION, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BESDATA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  1.  K211347  Uretero1 Ureteroscope System
  2.  K223466  Uretero1 Single-Use Digital Flexible Ureteroscope ...
  3.  K231878  Uretero1 Single-Use Digital Flexible Ureteroscope ...
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 402 402
2021 325 325
2022 455 455
2023 458 458
2024 574 574
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 564 564
Microbial Contamination of Device 238 238
Adverse Event Without Identified Device or Use Problem 202 202
Failure to Clean Adequately 190 190
Device Reprocessing Problem 149 149
Mechanical Problem 97 97
Detachment of Device or Device Component 78 78
Peeled/Delaminated 61 61
No Display/Image 61 61
Material Protrusion/Extrusion 59 59
Material Split, Cut or Torn 59 59
Poor Quality Image 59 59
Contamination 42 42
Fluid/Blood Leak 39 39
Material Twisted/Bent 34 34
Material Puncture/Hole 34 34
Physical Resistance/Sticking 34 34
Appropriate Term/Code Not Available 31 31
Scratched Material 26 26
Mechanical Jam 25 25
Crack 24 24
Material Deformation 24 24
Material Separation 24 24
Device Contamination with Chemical or Other Material 23 23
Leak/Splash 23 23
Corroded 22 22
Contamination /Decontamination Problem 21 21
Insufficient Information 19 19
Defective Component 16 16
Device Displays Incorrect Message 15 15
Unsealed Device Packaging 14 14
Loose or Intermittent Connection 14 14
Optical Problem 14 14
Degraded 13 13
Material Fragmentation 13 13
Defective Device 12 12
Erratic or Intermittent Display 11 11
Use of Device Problem 11 11
Unintended Movement 10 10
Difficult to Remove 10 10
Component Missing 9 9
Material Integrity Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Melted 8 8
Problem with Sterilization 8 8
Display or Visual Feedback Problem 7 7
Device Damaged by Another Device 7 7
Material Perforation 7 7
Fracture 6 6
Sharp Edges 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1441 1441
No Consequences Or Impact To Patient 220 220
Urinary Tract Infection 166 166
No Patient Involvement 89 89
Fever 75 75
Unspecified Infection 73 73
Insufficient Information 49 49
No Known Impact Or Consequence To Patient 44 44
Pain 28 28
Sepsis 25 25
Unspecified Kidney or Urinary Problem 25 25
Foreign Body In Patient 23 23
Injury 21 21
Bacterial Infection 15 15
Hemorrhage/Bleeding 11 11
Hematuria 10 10
Laceration(s) 10 10
Perforation 9 9
Septic Shock 8 8
Urinary Frequency 8 8
Renal Failure 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Inflammation 6 6
Urethral Stenosis/Stricture 5 5
Urinary Retention 5 5
Obstruction/Occlusion 5 5
Nausea 5 5
Chills 4 4
Unspecified Tissue Injury 4 4
Rupture 3 3
Hematoma 3 3
Discomfort 3 3
No Code Available 3 3
Abrasion 3 3
Physical Entrapment 3 3
Abscess 2 2
Swelling/ Edema 2 2
Device Embedded In Tissue or Plaque 2 2
Burn(s) 2 2
Hepatitis 2 2
Death 2 2
Vomiting 2 2
Low Blood Pressure/ Hypotension 2 2
Bowel Burn 2 2
No Information 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Renal Impairment 2 2
Internal Organ Perforation 2 2
Muscle Weakness 1 1
Device Overstimulation of Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Oct-10-2024
2 Aizu Olympus Co., Ltd. II Nov-17-2023
3 Karl Storz Endoscopy II Jan-30-2025
4 Karl Storz Endoscopy II May-12-2022
5 Olympus Corporation of the Americas II Jun-13-2022
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